Ascendis Pharma Reports First Quarter 2024 Financial Results
Ascendis Pharma reported strong financial results for the first quarter of 2024, with notable achievements including the initiation of YORVIPATH® rollout, significant revenue growth for SKYTROFA®, and key milestones for TransCon PTH and TransCon CNP.
Despite positive revenue growth and operational progress, Ascendis Pharma reported increased operating expenses, a net loss, and a decline in net finance income compared to the same period in 2023.
Significant revenue growth for SKYTROFA®, with Q1 revenue more than doubling year-over-year to €65 million.
Successful initiation of YORVIPATH® rollout in Germany and Austria with positive initial results.
Anticipated milestones for TransCon PTH and TransCon CNP on track, with topline data expected in Q4 2024.
Company remains on track to achieve full-year 2024 revenue targets for SKYTROFA® and operating expenses.
Increased operating expenses for the first quarter of 2024, totaling €137.5 million compared to €172.7 million in the same period in 2023.
Net loss of €131.0 million reported for Q1 2024, compared to a net loss of €110.9 million for the same period in 2023.
Decline in net finance income for Q1 2024, totaling €73.6 million compared to a net finance income of €35.3 million in the same period in 2023.
Insights
The substantial increase in SKYTROFA revenue reflects a strong market uptake for Ascendis Pharma's products, indicating effective penetration and growing demand. Notably, doubling the revenue year-over-year is a positive signal to investors about the company's growth trajectory. The reduction in operating expenses, particularly R&D, suggests a strategic streamlining of costs that could enhance profitability margins moving forward.
Ascendis Pharma's forecasted break-even point by the end of 2024 presents a potential turning point for the company's financial performance. This would mark a significant milestone for the company, transitioning from a cash-burning development phase to a more sustainable operational phase. Investors should pay close attention to the progress of PDUFA dates and clinical trial results as they can heavily influence the stock's performance due to their impact on the company's revenue potential and market expansion opportunities.
The progress of TransCon PTH (palopegteriparatide) and its potential approval could open a sizable market in the U.S., addressing the unmet medical needs in hypoparathyroidism, a space with limited therapeutic options. Similarly, the pipeline progression of TransCon CNP (navepegritide) is critical, as it targets achondroplasia, a rare condition without many therapeutic alternatives. Positive trial results could lead to a new drug application, which would significantly bolster the company's portfolio and value proposition.
The cash and marketable securities position, although decreased from the previous quarter, provides sufficient runway for the company to execute its strategic plans without immediate dilutive financing, which is reassuring for shareholders valuing stability and reduced risk of capital erosion.
Ascendis Pharma's strategic positioning towards three independent Endocrinology Rare Disease blockbuster products aligns with the current market trend of focusing on highly specialized medications that command premium pricing. This is particularly relevant given the increased scrutiny on drug pricing and reimbursement. Moreover, the expansion into larger therapeutic areas such as Oncology offers a diversified risk profile and potential for significant value creation, although it brings a different set of challenges and competition levels.
Understanding the market dynamics, such as the number of patients and prescribing doctors for YORVIPATH in Germany and Austria, provides insight into market reception and potential for expansion into other territories. The company’s prudent approach to R&D investment, particularly in later-stage assets, heightens the credibility of its commercial strategy.
— Rollout of YORVIPATH® initiated in Germany and Austria, with an estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31
— TransCon™ PTH (palopegteriparatide) PDUFA date of May 14, 2024, for adults with hypoparathyroidism. If approved, U.S. launch planned in Q3
— TransCon CNP (navepegritide) pivotal ApproaCH Trial on track for topline results in Q4 2024
— SKYTROFA® Q1 revenue more than doubled year-over-year to
— Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of
— Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, May 02, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the first quarter ended March 31, 2024, and provided a business update.
“With SKYTROFA revenue more than doubling in the U.S. compared to the first quarter of 2023, and our successful initial launch of YORVIPATH in Germany and Austria, we believe Ascendis is on the path to achieving sustainable growth and operating cash flow breakeven on a quarterly basis by the end of 2024,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Our achievements this quarter give me further confidence that all elements are in place to deliver three independent Endocrinology Rare Disease blockbuster products and a strong pipeline in larger therapeutic areas such as Oncology, Ophthalmology, and Metabolic Diseases as outlined in Vision 2030.”
Select Highlights & Anticipated 2024 Milestones
- TransCon hGH:
(lonapegsomatropin, approved as SKYTROFA in the U.S., EU, European Economic Area (EEA) countries, and Great Britain)- First quarter 2024 SKYTROFA revenue totaled
€65 million , a106% year over year increase with a steady quarter to quarter increase in treated patients. - Full year 2024 SKYTROFA revenue expected to be
€320 million to€340 million (based on average 2023 exchange rates). - Plan to submit a supplemental Biologics License Application to FDA for adult growth hormone deficiency (GHD), in the third quarter of 2024.
- Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
- First quarter 2024 SKYTROFA revenue totaled
- TransCon PTH:
(palopegteriparatide, approved as YORVIPATH in the EU, EEA countries, and Great Britain)- Commercial rollout of YORVIPATH continues in Germany and Austria with an estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31. First quarter YORVIPATH revenue totaled
€1.5 million reflecting first two months of delivery to patients. - In the U.S., Prescription Drug User Fee Act (PDUFA) date of May 14, 2024; if approved, U.S. commercial launch planned in the third quarter of 2024.
- Granted marketing authorization for the treatment of adults with chronic hypoparathyroidism and orphan drug status in Great Britain.
- Commercial rollout of YORVIPATH continues in Germany and Austria with an estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31. First quarter YORVIPATH revenue totaled
- TransCon CNP:
(navepegritide)- Topline data from pivotal ApproaCH Trial expected in the fourth quarter of 2024, and plan to submit a New Drug Application to FDA for children with achondroplasia (age 2-11 years) in the same quarter.
- Expect to initiate and complete enrollment in the combination TransCon hGH and TransCon CNP COACH trial of children with achondroplasia (ages 2-11) during the second quarter of 2024; topline Week 26 data expected in the fourth quarter of 2024.
- Oncology Programs
- New data from the ongoing Phase 1/2 IL-Believe Trial has been accepted for a poster presentation at the American Society for Clinical Oncology (ASCO) May 31-June 4. The presentation will provide initial data from the combination of TransCon IL-2 β/γ and TransCon TLR7/8 Agonists in patients with melanoma who have progressed on anti-PD1 therapy.
- During the fourth quarter of 2024, plan to provide a clinical update from the Phase 2 indication-specific, dose expansion cohorts from our TransCon IL-2 β/γ and TransCon TLR7/8 Agonist clinical trials.
- Financial Update and Outlook Based on Current Plans
- As of March 31, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling
€320 million compared to€399 million as of December 31, 2023. - Full year 2024 SKYTROFA revenue expected to be
€320 million to€340 million (based on average 2023 exchange rates). - Expect total operating expenses (SG&A and R&D) of approximately
€600 million for 2024. - Expect to be operating cash flow breakeven on a quarterly basis by the end of 2024.
- As of March 31, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling
First Quarter 2024 Financial Results
Total revenue for the first quarter of 2024 was
| Total Revenue (In EUR'000s) | Three Months Ended March 31, | ||||||
| 2024 | 2023 | ||||||
| Revenue from external customers | |||||||
| Commercial sale of products | 66,499 | 31,551 | |||||
| Licenses | 24,770 | 614 | |||||
| Other | 4,625 | 1,424 | |||||
| Total revenue from external customers | 95,894 | 33,589 | |||||
Research and development (R&D) costs for the first quarter of 2024 were
Selling, general, and administrative (SG&A) expenses for the first quarter of 2024 were
Total operating expenses for the first quarter of 2024 were
Net finance expenses for the first quarter of 2024 were
For the first quarter of 2024, Ascendis Pharma reported a net loss of
As of March 31, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling
Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its first quarter 2024 financial results.
Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) TransCon PTH’s PDUFA date of May 14, 2024, (ii) the commercial launch of TransCon PTH in the U.S., if approved, (iii) the timing of topline results from the ApproaCH Trial, (iv) Ascendis’ expectations regarding full year 2024 revenue for SKYTROFA, (v) Ascendis’ ability to fulfill its strategic goals to deliver three independent Endocrinology Rare Disease blockbuster products and a strong pipeline in larger therapeutic areas such as Oncology, Ophthalmology, and Metabolic Diseases, (vi) Ascendis’ plan to submit a supplemental Biologics License Application for SKYTROFA for adult GHD in the third quarter of 2024, (vii) the timing of topline results from the Phase 2 trial in Turner syndrome, (viii) the timing of topline data from the ApproaCH Trial, (ix) Ascendis’ plan to submit a New Drug Application for TransCon CNP for children with achondroplasia, (x) Ascendis’ ability to initiate and complete enrollment in the COACH Trial, (xi) the timing of topline data from Week 26 of the COACH Trial, (xii) Ascendis’ plan to present initial data from the Phase 1/2 IL-Believe Trial, (xiii) Ascendis’ plan to provide a clinical update from the Phase 2 portion of indication-specific, dose expansion cohorts of the IL Believe trial, (xiv) Ascendis’ expectations regarding its total operating expenses for 2024, (xv) Ascendis’ expectation that it will be operating cash flow breakeven on a quarterly basis by the end of 2024, (xvi) Ascendis’ belief that it is on a path to achieving sustainable growth and that all elements are in place to deliver three independent Endocrinology Rare Disease blockbuster products, (xvii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xviii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA®, and YORVIPATH® are trademarks owned by the Ascendis Pharma group.
© May 2024 Ascendis Pharma A/S.
| Investor Contacts: | Media Contact: |
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| Ascendis Pharma | Ascendis Pharma |
| +1 (650) 374-6343 | +1 (650) 709-8875 |
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FINANCIAL TABLES FOLLOW
| Ascendis Pharma A/S Consolidated Statements of Profit or Loss and Comprehensive Income / (Loss) (In EUR'000s, except share and per share data) | Three Months Ended March 31, | ||||||
| 2024 | 2023 | ||||||
| Consolidated Statement of Profit or Loss | |||||||
| Revenue | 95,894 | 33,589 | |||||
| Cost of sales | 7,569 | 4,621 | |||||
| Gross profit | 88,325 | 28,968 | |||||
| Research and development costs | 70,687 | 106,114 | |||||
| Selling, general and administrative expenses | 66,783 | 66,539 | |||||
| Operating profit/(loss) | (49,145 | ) | (143,685 | ) | |||
| Share of profit/(loss) of associate | (5,796 | ) | (1,227 | ) | |||
| Finance income | 3,575 | 45,135 | |||||
| Finance expenses | 77,161 | 9,840 | |||||
| Profit/(loss) before tax | (128,527 | ) | (109,617 | ) | |||
| Income taxes/(expenses) | (2,508 | ) | (1,297 | ) | |||
| Net profit/(loss) for the period | (131,035 | ) | (110,914 | ) | |||
| Attributable to owners of the Company | (131,035 | ) | (110,914 | ) | |||
| Basic and diluted earnings/(loss) per share | € | (2.30 | ) | € | (1.98 | ) | |
| Number of shares used for calculation (basic and diluted) | 56,883,257 | 56,091,927 | |||||
| Consolidated Statement of Comprehensive Income or (Loss) | |||||||
| Net profit/(loss) for the period | (131,035 | ) | (110,914 | ) | |||
| Items that may be reclassified subsequently to profit or loss: | |||||||
| Exchange differences on translating foreign operations | 63 | (787 | ) | ||||
| Other comprehensive income/(loss) for the period, net of tax | 63 | (787 | ) | ||||
| Total comprehensive income/(loss) for the period, net of tax | (130,972 | ) | (111,701 | ) | |||
| Attributable to owners of the Company | (130,972 | ) | (111,701 | ) | |||
| Ascendis Pharma A/S Consolidated Statements of Financial Position (In EUR'000s) | March 31, 2024 | December 31, 2023 | |||||
| Assets | |||||||
| Non-current assets | |||||||
| Intangible assets | 4,301 | 4,419 | |||||
| Property, plant and equipment | 107,164 | 110,634 | |||||
| Investment in associates | 24,797 | 5,686 | |||||
| Other receivables | 2,129 | 2,127 | |||||
| 138,391 | 122,866 | ||||||
| Current assets | |||||||
| Inventories | 232,681 | 208,931 | |||||
| Trade receivables | 41,092 | 35,874 | |||||
| Income tax receivables | 742 | 802 | |||||
| Other receivables | 26,857 | 19,097 | |||||
| Prepayments | 42,502 | 38,578 | |||||
| Marketable securities | — | 7,275 | |||||
| Cash and cash equivalents | 320,239 | 392,164 | |||||
| 664,113 | 702,721 | ||||||
| Total assets | 802,504 | 825,587 | |||||
| Equity and liabilities | |||||||
| Equity | |||||||
| Share capital | 7,818 | 7,749 | |||||
| Distributable equity | (245,997 | ) | (153,446 | ) | |||
| Total equity | (238,179 | ) | (145,697 | ) | |||
| Non-current liabilities | |||||||
| Borrowings | 229,627 | 222,996 | |||||
| Contract liabilities | 5,000 | 5,949 | |||||
| Deferred tax liabilities | 7,085 | 5,830 | |||||
| 241,712 | 234,775 | ||||||
| Current liabilities | |||||||
| Convertible notes, matures in April 2028 | |||||||
| Borrowings | 424,984 | 407,095 | |||||
| Derivative liabilities | 197,291 | 143,296 | |||||
| 622,275 | 550,391 | ||||||
| Other current liabilities | |||||||
| Borrowings | 14,403 | 14,174 | |||||
| Contract liabilities | 1,183 | 1,184 | |||||
| Trade payables and accrued expenses | 94,526 | 94,566 | |||||
| Other liabilities | 22,698 | 41,176 | |||||
| Income tax payables | 3,336 | 2,299 | |||||
| Provisions | 40,550 | 32,719 | |||||
| 176,696 | 186,118 | ||||||
| 798,971 | 736,509 | ||||||
| Total liabilities | 1,040,683 | 971,284 | |||||
| Total equity and liabilities | 802,504 | 825,587 | |||||
FAQ
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